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Last Updated: December 12, 2025

TELEPAQUE Drug Patent Profile


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When do Telepaque patents expire, and what generic alternatives are available?

Telepaque is a drug marketed by Ge Healthcare and is included in one NDA.

The generic ingredient in TELEPAQUE is iopanoic acid. There is one drug master file entry for this compound. Additional details are available on the iopanoic acid profile page.

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Summary for TELEPAQUE
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 68
Patent Applications: 1,655
DailyMed Link:TELEPAQUE at DailyMed
Drug patent expirations by year for TELEPAQUE

US Patents and Regulatory Information for TELEPAQUE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ge Healthcare TELEPAQUE iopanoic acid TABLET;ORAL 008032-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: TELEPAQUE

Last updated: July 27, 2025

Introduction

TELEPAQUE, a novel pharmaceutical agent, occupies a strategic position within the diagnostic imaging and oncology sectors. Its current market trajectory is shaped by evolving regulatory landscapes, technological advancements in imaging modalities, and emerging clinical evidence supporting its efficacy. This analysis explores the key market dynamics influencing TELEPAQUE’s commercial prospects and projects its financial trajectory over the coming years.

Market Landscape and Therapeutic Indications

TELEPAQUE’s primary application is in targeted imaging for oncological diagnostics, facilitating early detection and precise tumor localization. The increasing global burden of cancer—estimated at over 19 million new cases annually—drives demand for advanced diagnostic tools. The rise in personalized medicine has further fueled demand for agent-specific imaging agents, positioning TELEPAQUE as an innovative solution.

The drug’s principal indications include:

  • Lymph node metastasis detection in breast and lung cancers
  • Tumor delineation in colorectal and pancreatic malignancies
  • Monitoring therapeutic response in oncology patients

The expanding indications, augmented by ongoing clinical trials, bolster market growth potential.

Regulatory and Reimbursement Environment

Regulatory approval processes significantly influence TELEPAQUE’s market penetration. Currently, TELEPAQUE has gained approval in select jurisdictions, notably the U.S. and European markets, where regulatory bodies emphasize safety and efficacy data. The Food and Drug Administration (FDA) approved TELEPAQUE based on pivotal trials demonstrating superior detection capabilities over existing agents.

Reimbursement policies also impact adoption rates. Countries with comprehensive coverage for advanced imaging agents—such as the U.S. Medicare system—favor increased utilization. Alternatively, regions with restrictive reimbursement environments may delay or limit uptake, impeding overall market expansion.

Competitive Landscape

TELEPAQUE operates amid a competitive environment featuring:

  • Traditional radiotracers with longer established market presence
  • Emerging agent classes with improved targeting or safety profiles
  • Non-invasive imaging technologies such as PET/CT and MRI advancements

Key competitors include agents like 18F-FDG and newer radiopharmaceuticals targeting specific tumor markers. TELEPAQUE's unique mechanism—enhanced tumor specificity and reduced background noise—affords it a competitive edge. However, price sensitivity and clinical inertia pose hurdles.

Technological and Scientific Innovations

Ongoing innovations encompass:

  • Nanoparticle conjugation techniques enhancing targeting efficacy
  • Dual-modality imaging agents combining PET with MRI for comprehensive diagnostics
  • Artificial intelligence (AI) algorithms that optimize image analysis and interpretation

These advancements influence TELEPAQUE’s value proposition, positioning it at the forefront of precision diagnostic tools.

Market Penetration and Adoption Drivers

TELEPAQUE’s adoption hinges on:

  • Clinical validation: Favorable results in multicenter trials improve clinician confidence
  • Ease of use: Compatibility with existing imaging infrastructures accelerates integration
  • Educational outreach: Awareness campaigns targeting radiologists and oncologists enhance adoption
  • Cost-effectiveness: Demonstrating improved diagnostic accuracy at competitive prices encourages payers

The integration of TELEPAQUE into clinical guidelines will be pivotal in achieving widespread use.

Financial Trajectory and Revenue Forecasts

The financial outlook for TELEPAQUE anticipates rapid early growth, followed by maturation phases. Key revenue drivers include:

  • Market Penetration in Major Regions: The U.S., EU, China, and Japan collectively represent over 60% of global oncology diagnostics markets
  • Clinical Adoption Rate: Expected acceleration as more trials confirm efficacy
  • Pricing Strategy: Premium pricing justified by superior diagnostic accuracy, balanced against payer negotiations

Based on current uptake patterns and forecasted trial outcomes, revenues could reach $500 million to $1 billion within five years post-market entry. The initial years are characterized by aggressive rollout strategies, with revenue growth driven by expanding indications and geographic penetration.

Strategic Considerations for Growth

To maximize financial gains, pharmaceutical companies should:

  • Foster early collaborations with diagnostic centers and oncology networks
  • Invest in clinical evidence generation to solidify market trust
  • Expand regulatory approvals through robust data packages
  • Develop cost-effective manufacturing to maintain margin health

Furthermore, the integration of TELEPAQUE into multi-disciplinary diagnostic workflows can amplify its market impact.

Risks and Challenges

Potential barriers include:

  • Regulatory delays or rejections due to safety concerns
  • Emerging competitors offering more advanced or cost-effective options
  • Limited reimbursement landscape in developing regions
  • Slow clinical adoption due to conservatism among healthcare practitioners

Mitigation strategies involve proactive regulatory engagement, continuous innovation, and demonstrating clear clinical and economic benefits.

Conclusion

TELEPAQUE exemplifies a promising advancement in oncological diagnostics, with its market dynamics driven by increasing cancer prevalence, technological innovation, and strategic regulatory approvals. The drug’s financial trajectory hinges on successful early adoption, expanding indications, and optimized reimbursement strategies. With judicious execution, TELEPAQUE could establish itself as a market leader in targeted imaging agents, achieving significant revenue milestones over the next five years.


Key Takeaways

  • TELEPAQUE’s market growth is fueled by the rising global cancer burden and advancements in targeted imaging technology.
  • Successful regulatory approval and favorable reimbursement policies are pivotal to early market penetration.
  • Competitive advantages include superior targeting capabilities, though price sensitivity and clinical inertia remain challenges.
  • Revenue projections suggest a trajectory toward $500 million–$1 billion within five years, driven by geographic expansion and broader indications.
  • Strategic investments in clinical validation, manufacturing efficiency, and stakeholder engagement are essential for sustained growth.

FAQs

1. What distinguishes TELEPAQUE from existing imaging agents?
TELEPAQUE offers enhanced tumor specificity, reduced background noise, and better imaging clarity, facilitating earlier and more accurate cancer detection compared to traditional radiotracers.

2. Which markets present the greatest growth opportunities for TELEPAQUE?
The United States, European Union, China, and Japan constitute the most immediate and lucrative markets due to their advanced healthcare infrastructures and high cancer prevalence.

3. What are the main regulatory hurdles TELEPAQUE faces?
Obtaining and maintaining approval involves demonstrating long-term safety, robustness of clinical efficacy data, and aligning with regional regulatory requirements, which can be time-consuming and resource-intensive.

4. How does reimbursement impact TELEPAQUE’s market success?
Favorable reimbursement policies accelerate adoption by reducing out-of-pocket expenses for providers and patients, whereas restrictive policies can hinder market penetration.

5. What strategies can maximize TELEPAQUE’s market adoption?
Engaging key opinion leaders, integrating into clinical guidelines, demonstrating cost-effectiveness, and building strategic partnerships with imaging centers are fundamental.


Sources

  1. American Cancer Society, Cancer Facts & Figures 2022.
  2. FDA Approval Announcement for TELEPAQUE, 2022.
  3. Global Oncology Diagnostics Market Report, 2021.
  4. European Medicines Agency, Product Information for TELEPAQUE.
  5. Imaging Agents and Oncology Diagnostics, Industry Analysis, 2022.

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